MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG ENDO-MODEL SL; MODULAR STEMS, WITH FEMALE TAPER

Model Number	15-8515/55
Medical Device Problem Codes	Osseointegration Problem (3003); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/20/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Dr.Revised the patient's loosened tibial component and stem.These components were originally implanted on (b)(6) 2016.The patient has undergone several subsequent revisions of other parts of the total knee replacement (documented in complaints: (b)(4).This tibial tray and stem (implanted 2016) were revised to a custom-made tibial implant (cus-690) on (b)(6) 2022.Per dr., the cause of the loosened tibia was "terrible bone stock.Too small a diameter stem and probably not long enough as well.
Additional Manufacturer Narrative
The review of the device history record showed no deviations.The product complies with the specifications valid at the time of manufacture.
Event or Problem Description
The patient had undergone several prior revisions following revision total knee replacement performed in (b)(6) 2016, with preceding history or limb salvage surgery and infected total knee arthroplasty.This tibial tray and stem (implanted in 2021) were revised to a custom-made implant.Per dr.M., the cause of the loosened tibia was "terrible bone stock.Too small a diameter stem and probably not long enough as well.".

• Brand Name: ENDO-MODEL SL
• Common Device Name: MODULAR STEMS, WITH FEMALE TAPER
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, 22339 ; GM 22339
• Manufacturer Contact: lisa effe ; barkhausenweg 10; hamburg, 22339 ; GM 22339
• MDR Report Key: 16172827
• Report Number: 3004371426-2023-00002
• Device Sequence Number: 2428851
• Product Code: KRO
• UDI-Device Identifier: 04026575384006
• UDI-Public: 04026575384006
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K151008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2023
• Device Model Number: 15-8515/55
• Device Catalogue Number: 15-8515/55
• Device Lot Number: 1816112
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2022
• Supplement Date Received by Manufacturer: 12/22/2022
• Initial Report FDA Received Date: 01/16/2023
• Supplement Report FDA Received Date: 05/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male